AMAL Therapeutics, a Swiss biotech developing peptide-based therapeutic cancer vaccines, has entered into a collaborative agreement with Boehringer Ingelheim under which AMAL will conduct a Phase Ib study, (KISIMA-01), to evaluate the combination of its lead candidate, ATP128, with Boehringer’s anti-PD1 compound, BI754091, in Microsatellite Stable (MSS) patients with stage IV colorectal cancer.
 
AMAL’s lead candidate, ATP128, is a chimeric recombinant protein designed using AMAL’s proprietary vaccine technology platform, KISIMA. ATP128 comprises a cell penetrating peptide (CPP) for antigen delivery, a TLR peptide agonist for self-adjuvanticity and a multiple antigenic domain (Mad).
 
The study will investigate the safety and tolerability of ATP128 as single agent and in combination with BI754091 as its primary objective, and the anti-tumor activity and the characteristics of the immune response will be evaluated as secondary objectives.
The clinical study will be sponsored by AMAL and Boehringer will provide BI754091for the trial. The study results will be jointly owned. AMAL retains full development and commercialization rights to ATP128 and the KISIMA technology platform.
 
“Our strong in-vivo data package for combination therapies demonstrated synergies between ATP128 and immune checkpoint inhibitors, which laid the basis for this first-in-human clinical study. We are excited to evaluate ATP128 in combination with BI754091 in different patient populations with stage IV colorectal cancer, and to show the value of our lead candidate and the potential of the KISIMA platform” said Madiha Derouazi, chief executive officer and founder of AMAL Therapeutics.